目的 比較并討論《美國藥典》和《中國藥典》中泮托拉唑鈉有關(guān)物質(zhì)的檢測方法，為完善泮托拉唑鈉腸溶膠囊及腸溶片中泮托拉唑鈉有關(guān)物質(zhì)的檢測方法提供科學(xué)依據(jù)。方法 采用Inertsil ODS-3柱（梯度方法100 mm×4.0 mm，5 μm；等度方法250 mm×4.6 mm，5 μm），分別用《中國藥典》2005年版（ChP 2005）、2010年版（Chp 2010）和美國藥典32-NF27版（USP 32-NF27）原料及制劑方法測定泮托拉唑鈉有關(guān)物質(zhì)，并對其專屬性及酸破壞結(jié)果進(jìn)行比較。結(jié)果 ChP 2010與USP 32-NF 27原料方法專屬性優(yōu)于另外兩種方法，能將泮托拉唑鈉及其有關(guān)物質(zhì)較好地分離，二者分離效果基本一致，檢出雜質(zhì)的量也基本一致，各雜質(zhì)相對保留時間近似相同。結(jié)論 ChP 2010尚無關(guān)于片劑或膠囊劑質(zhì)量標(biāo)準(zhǔn)的相關(guān)規(guī)定。泮托拉唑鈉腸溶膠囊國家藥品標(biāo)準(zhǔn)WS₁-(X-198)-2004Z與泮托拉唑鈉腸溶片國家藥品標(biāo)準(zhǔn)WS₁-(X-120)-2003Z中有關(guān)物質(zhì)檢查項仍沿用ChP 2005方法，檢出雜質(zhì)較少，無法客觀評價其質(zhì)量。因此建議將泮托拉唑鈉腸溶膠囊國家藥品標(biāo)準(zhǔn)及泮托拉唑鈉腸溶片國家藥品標(biāo)準(zhǔn)有關(guān)物質(zhì)檢查方法改為更能客觀評價其質(zhì)量的ChP 2010泮托拉唑鈉原料有關(guān)物質(zhì)檢查方法，并對雜質(zhì)峰的位置及單一雜質(zhì)限度作出詳細(xì)規(guī)定。

Objective To optimize the method for the determination of the related substances of Pantoprazole Sodium after comparing different HPLC methods in the United States Pharmacopeia (USP) and Chinese Pharmacopoeia (ChP). Metohods Two Inertsil ODS-3 columns (100 mm × 4.0 mm, 5 μm for gradient elution and 250 mm × 4.6 mm, 5 μm for isocratic elution) were used according to the method in ChP 2005, ChP 2010, as well as the USP 32-NF 27 methods for bulk drug and pharmaceutics, respectively, and the results of specificity and destructive tests were compared. Results The ChP 2010 and USP 32-NF 27 methods for the bulk drug, with consistent resolution, content, and retention time of the impurities, are of higher specificity than the others and could separate the related substances of pantoprazole sodium well. Conclusion Since there is no quality specification about cuteric-coated capsules and tablets of Pantoprazole Sodium in ChP 2010, the method to determine the related substances of Pantoprazole Sodium enteric-coated capsules and tablets is still referred from ChP 2005 although with low specificity. The ChP 2010 method applied to the determination of the related substances of bulk drug is proposed to determine the related substances of pantoprazole sodium enteric-coated capsules and tablets, with the retention time and content limit of each impurity specified.